In many medical applications, it is necessary to connect one section of medical tubing, e.g., a catheter, with another. Generally speaking, it is important that these connections be relatively secure and stable so that the catheter does not separate or develop leaks at the connection point. Security and leak-resistance take on special importance in applications where the catheter sections are implanted in a human body.
One procedure that necessitates implantation of a catheter into the body involves the use of an implantable medical device, e.g., a drug infusion pump. Such implantable medical devices are often used to control pain and/or spasticity, as well as to provide one or more drugs or fluid medications to a particular location within the body. For instance, a typical implant procedure may involve implanting a drug infusion pump into a cavity or subcutaneous pocket in the body and delivering a drug, via catheter(s), to an epidural space or intrathecal space of the spinal column or to a particular location within the brain.
A distal catheter section may be positioned in the desired location in the body and then connected to a proximal catheter section by use of a connector. The connection may be made by inserting one end or prong of the connector into a lumen of one catheter section (e.g., the proximal section) and the other end of the connector into the lumen of the other catheter section (e.g., the distal section) and then sliding both catheter sections towards one another (toward the middle of the connector). The proximal section may then be connected to the drug infusion pump.
While adequate, difficulties have been encountered in the manufacture and use of such prior art connectors. For example, an inadequate seal between the catheter and the connector may be formed during assembly or the catheters and/or connector may be damaged during assembly. Also, these connectors, which have been sized to fit within the lumens of the catheter sections, are small and may be difficult to manipulate during implantation. Moreover, because some of these connectors fit entirely within the lumens of the respective catheter sections, it is often difficult for the implanting clinician (e.g., a surgeon) to be sure that the interface between catheter sections is positioned at, or even near, the center of the connector (i.e., it may be difficult to center the catheter sections on the connector). Misalignment of the connector can result in a weakened connection that is more likely to separate and/or develop leaks. Other potential problems include: lack of ability to adequately secure the catheters relative to one another; and inability to provide sufficient strain relief to the connection.